How to formulate a research question, steps, types and common flaws and types of research study designs

1. Dr. Mona Al Sheikh
Research Question

2. Components of RQ
Formulating a RQ
How to develop RQ? Video
Types of RQs
Examples of Good and Flawed RQs

3. Research question is like a mission
statement. It determines many
actions that follow like the design,
the subjects, the indicator to be
measured and even the statistical or
qualitative analysis to be used.
Definition of Research Question

4. Components of a Research Question

5. Participants/Population/Problem
● Age
● Gender
● Ethnicity
● Nationality
● Education level
● Social status
● Socioeconomic level
● Family disease history

6. Intervention/exposure
● Drug/chemical/herb
● Physical activity
● Food intake/fasting
● Electric stimulation/thermal/vibration
● Instruction modality
● Behavior modification
● Exposure to sunlight/radiation/sounds
● Sleep deprivation
● TENS/Acupuncture

7. Comparison/alternative
● Tranditional curriculum
● Another classic treatment
● Different instructional strategy/assessment tool
● No intervention
● Placebo
● Prognostic factor
● Absence of risk factor

8. Outcome
● BMI
● Memory and retention/learning/Performance
● Pain threshold
● Sleep quality
● Addictive behavior
● Bone density
● Headache/migraine/seizure
● Mood

9. Study
● Qualitative
● Quantitative
● Correlation
● RCT
● Multivariate analysis

10. Characteristics of a good RQ
● Clear and focused. In other words, the question should clearly state what the
researcher needs to do.
● Not too broad and not too narrow. The question should have an
appropriate scope. If the question is too broad it will not be possible to answer it
thoroughly within the word limit. If it is too narrow you will not have enough to
write about and you will struggle to develop a strong argument (see the activity
below for examples).
● Not too easy to answer. For example, the question should require more than
a simple yes or no answer.
● Not too difficult to answer. You must be able to answer the question
thoroughly within the given timeframe and word limit.
● Researchable. You must have access to a suitable amount of quality research
materials, such as academic books and refereed journal articles.
● Analytical rather than descriptive. In other words, your research question
should allow you to produce an analysis of an issue or problem rather than a
simple description of it (more on this below).

11. Consider the following when
developing a research question
Is it an open-ended question?
Is it appropriate in scope? Focused and narrow enough
Does it suggest factors that can be measured?
Is it relevant to my audience?
Is answering the question manageable?
Is the topic of interest to me?

12. Description of a Random Controlled Trial
● CONSORT 2010 : guideline intended to improve the
reporting of randomized controlled trials.
● SPIRIT 2013 : evidence based recommendations for the
minimum content of a controlled trial.
● TIDieR 2014 checklist: template for intervention description
and replication.

13. Formulating a Research Question

14. Activity I
Narrowing down your topic
● Create three columns on a piece of paper, in a word document, or
in a spreadsheet.
● Select a broad topic for an upcoming assignment or choose a topic
that you are interested in.
● In the first column write down the items contained in the first
column below. Add any other items that may be relevant to your
topic.
● In the second column write down potential sub-topics and other
limitations.
● In the third column write the potential value of what you have
written in the second column. What would that sub-topic or other
limitation allow you to prove or demonstrate?
● Circle or highlight the items in column two that have the strongest
potential value.

15. Activity I
Narrowing down your topic
● Create three columns on a piece of paper, in a word document, or
in a spreadsheet.
● Select a broad topic for an upcoming assignment or choose a topic
that you are interested in.
● In the first column write down the items contained in the first
column below. Add any other items that may be relevant to your
topic.
● In the second column write down potential sub-topics and other
limitations.
● In the third column write the potential value of what you have
written in the second column. What would that sub-topic or other
limitation allow you to prove or demonstrate?
● Circle or highlight the items in column two that have the strongest
potential value.

16. Breast Cancer Early Detection
Self Examination
Mammogram
Surgical Resection
Early Treatment
Better outcome
Prevent metastasis
Prevent mortality
Breast Cancer
Etiology
Genetic
Iatrogenic
Environmental
Prevention of BC
Genetic Engineering
Prevalence <5%

17. Activity II
Fine Tuning RQ
● What are the effects of using social media
in the online classroom?
● How does “Telegram” impact
synchronized online learning in UG
medical students ?

18. Activity II
Fine Tuning RQ
● ‘Is starting aspirin at 12 weeks of gestation
in women at risk of pre-eclampsia a useful
treatment?’
● Does starting aspirin in women at risk of
pre-eclampsia at 12 weeks of gestation
reduce the risk of preterm delivery when
compared with usual care?’

20. https://youtu.be/71-GucBaM8U
https://youtu.be/LWLYCYeCFak

21. Types of Research Questions

22. Descriptive
Comparative
Causal
Types of Research Questions
Types of Research Questions

23. Descriptive Research Question
A question for a study that aims to describe something
Examples:
• How many calories do Saudis consumer per day?
• What are the important factors that determine admission to
medical schools in the Kingdom?
• What proportion of Saudi students get accepted in top
American and Canadian universities?

24. Comparative Research Question
Comparative RQ focusses on comparison of the dependent variable
between two or more groups
Examples:
• What is the difference in average BMI between Saudi men and
women ?
• What is the difference perception of the Educational Environement
between traditional and PBL students?
• Which is more reliable in assessment of second year medical
students, multiple choice or extended matching items?

25. Causative Research Question
Describes a study that tries to find if one variable causes another
Example:
• What is the relationship between Educational Environement
measurement and educational strategy?
• What is the relationship between gender and BMI in Saudi Arabia?
• What is the relationship between contraceptive pill use and breast
cancer?

26. Examples
● Does medication help
alleviate attention deficit
hyperactivity disorder
(ADHD) symptoms? And
do kids need more exercise?

27. ● How effective are the
various types of medication
in treating elementary
students with ADHD?

28. ● How do artificial
sweeteners affect people?

29. ● How does aspartame affect
post-menopausal women
who suffer from migraines?

30. Summary
● PICOS
● Formulating a RQ: Broad idea, general RQ, refine RQ, final
tune RQ.
● Types of RQs: Descriptive, comparative, and analytic.
● Common mistakes: Too broad, indicator is not measurable,
outcome is vague, study design does not match.
● Tips:
Ø READ
Ø READ
Ø READ

31. References
● Lane S. A good study starts with a clearly defined question:
Research question 1 of 2: how to pose a good research
question. BJOG : an international journal of obstetrics and
gynaecology. 2018;125(9):1057-
● Sandberg J, Alvesson M. Ways of constructing research
questions: gap-spotting or problematization? Organization
(London, England). 2011;18(1):23-44.
● Lane S. The best evidence comes from the right study design,
not just randomised trials: Research question 2 of 2: the
importance of research design. BJOG : an international
journal of obstetrics and gynaecology. 2018;125(12):1504-.

32. References
● Hoffmann, T.C., Glasziou, P.P., Boutron, I., Milne, R., Perera,
R., Moher, D., Altman, D.G., Barbour, V., Macdonald, H.,
Johnston, M., Lamb, S.E., Dixon-Woods, M., McCulloch, P.,
Wyatt, J.C., Chan, A. & Michie, S. 2014, "Better reporting of
interventions: template for intervention description and
replication (TIDieR) checklist and guide", BMJ: British
Medical Journal, vol. 348, no. mar07 3, pp. g1687-g1687.
● Kamper, S.J. 2018, "Asking a Question: Linking Evidence
With Practice", The journal of orthopaedic and sports
physical therapy, vol. 48, no. 7, pp. 596-597.
● Lane, S. 2018, "A good study starts with a clearly defined
question: Research question 1 of 2: how to pose a good
research question", BJOG : an international journal of
obstetrics and gynaecology, vol. 125, no. 9, pp. 1057-1057.

33. Dr. Mona Al Sheikh
Research Design

35. Objectives
● Research definition
● Research purpose
● How to do research?
● General types of research
● Qualitative vs quantitative design
● Observational vs experimental design
● Types and hierarchy of quantitative design
● Importance of design
● Design report
● Observational study design

36. What is Research?
Research is any original and systematic
investigation undertaken in order to increase
knowledge, understanding, to establish facts
and principles. It comprises the creation of
ideas and generation of knowledge that lead to
new and substantial improved insights and/or
the development of new materials, devices,
products and processes.

37. Purpose of Research
● Finding answers to questions or solutions to problems
● Discovering new facts
● Testing theories to revise accepted theories or laws in
light of new facts
● Planning and National development

40. How to do Research
● Research is all about addressing an issue or answering a
question or solving a problem
● Identify an issue, question, or problem.
●Talk with people who want or need your study.
● Find out what's already known about it.
●Talk with experts and/or read their reviews and the
original research on the topic.
● Plan, cost, and do your study accordingly.
● Write it up and submit it for assessment.
● Submit it for publication.

43. Types of Research
● Fundamental vs Applied
● Descriptive vs Analytical
● Quantitative vs Qualitative
● Conceptual vs Empirical

44. Fundamental and Applied research
● Fundamental or basic research seeks new knowledge about a
certain process . For example “ How does a panic attach
occur”? Or “How is long memory stored in the brain?”
● Applied research seeks solutions to an existing problem. For
example “What is the best management of a panic disorder”?
Or “ What encourages long term memory and retention”?

45. Descriptive vs Analytic
● Descriptive research classifies, describes, compares, and
measures data. For example “ How students perceive their
educational environment”? Or “ How do parents of autistic
children face the disability”? Or “ How do breast cancer
patients feel about their disease”?
● analytical research focuses on cause and effect. For example:
“ Why do parents of autistic children divorce”? “What are the
reasons behind low evaluation of students of their teachers”? Or
“ Why do breast cancer patients have insomnia”?

46. Quantitative vs Qualitative
● Quantitative research measures numbers of a certain
phenomenon. For example, “To what extent are students
satisfied with their educational environment”? Or “ What is
the recovery rate of breast cancer patients”?
● Qualitative research describes the phenomenon. For example,
“ What are the best and worst experiences students had
during their medical school”? Or “ How do breast cancer
patients perceive family members reaction to their illness”?

47. Conceptual vs Empirical
● Conceptual research involves abstract ideas and concepts and
the researcher uses the literature to explain a particular
phenomenon and is the basis of philosophical research. For
example, “ How do initial expectations of researcher
influence study results”?
● Empirical research involves research based on observation,
experiments and verifiable evidence. The conclusions of this
research are based on concrete evidence and observations.
For example, “ To what extent does taking iron supplements
prevent pregnancy anemia”?

48. Types of Empirical Research

49. Qualitative vs Quantitative Research
Quantitative
Methods
Observational
Experimental
Mixed
Sampling: Random
(simple, stratified, cluster,
etc) or purposive
Qualitative
Methods
Focus Groups
Interviews
Surveys
Self-reports
Observations
Document analysis
Sampling: Purposive

50. Research
Designs
Qualitative Quantitative
Experimental
Observational

51. Experimental
True
Experimental
Quasi
Experimental

53. RESEARCH METHODOLOGY

55. Descriptive Studies
Descriptive research is an observational / non – experimental
research design which is designed to discover new meanings and
to provide new knowledge where there is very little known about
the phenomena of interest.
It is designed to gather descriptive information and provides
information for formulating more sophisticated studies.
Description and explanation are its two aims.
Descriptive research aims at identifying the various
characteristics of a community or problem under study but it does
not deal with testing of hypothesis, in fact it leads to hypothesis
testing by exploring the problem.

56. Observational Research Designs
● Descriptive Design
● Case Study
● Case Series
● Cross – Sectional Designs
● Descriptive Cross – Sectional
● Analytical Cross – Sectional
● Correlational Design or Ecological Design
● Retrospective Design (Case – Control Study)
● Prospective Design (Cohort Study)

57. Case Study
A case study (case report) is a method of
descriptive research that documents a
practitioner’s experiences, thoughts, or
observations related to the care of a single client.
Case Series
A case series combines the observations from a
group of similar clients

58. Case Studies Usually Feature
● New disease or condition
● Rare or sparsely reported condition
● Unusual presentation of a common disease
● Impact of one disease process on another
● Unexpected event in the course of observing or
treating a patient
● Impact of a treatment regime of one condition on
another condition
● Unexpected complication of treatment or
procedure
● New and unique treatment

60. Cross-sectional studies
● Cross-Sectional Studies measure existing disease and
current exposure levels.
● They provide some indication of the relationship
between the disease and exposure or non-exposure.
● Sample at one point in time
● Mostly prevalence studies

62. Case-control studies
● Case-Control Studies identify existing disease/s and
look back in previous years to identify previous
exposures to causal factors.
● Cases are those who have a disease.
● Controls are those without a disease.

63. Activity I
Narrowing down your topic

64. Analytical Studies: Summary
Cost Cross
Sectional
Case Control Cohort RCT
Duration
Sample size
Incidence/
Prevalence
Multiple
Outcomes
Bias Prone
Causality

65. Analytical Studies: Summary

66. Activity III
Narrowing down your topic

67. Cross Sectional Study Design

68. Example of a Cross-Sectional Study
Association between garlic consumption and CAD
in the Family Practice Clinic

69. Cross-sectional Study
Sample of Population
Garlic Eaters Non-Garlic Eaters
Prevalence of
CAD
Prevalence of
CAD
Time Frame = Present

70. Cross-sectional Study
Garlic Consumption
+ -
C
A
D
+
- 90
10 90
10

71. Advantages
● Good design for hypothesis generation
● Can estimate overall and specific disease prevalence
and sometimes rates
● Can estimate exposure proportions in the population
● Can study multiple exposures
● Relatively easy, quick and inexpensive
● No issue of subjecting any animals or producers to
particular treatments
● Often good first step for new study issue

72. Disadvantages
● Impractical for rare diseases
● Not a useful type of study for establishing causal
relationships
● Confounding is difficult to control
● Recall of previous exposure may be faulty

73. Activity II
Narrowing down your topic

74. The Past The Present
Exposure
present
Exposure
present
Sample
of cases
Population
with disease
(cases)
Sample
of controls
Much larger
population
without
disease
(controls)
No
Outcome
Outcome
Exposure
absent
Exposure
absent
Case-Control Design

76. Example of a Case-Control Study
Oral Contraceptive use and breast Cancer?

77. Example of Case-Control Design: OC
Use and Breast Cancer
The Past or Present The Present
OC Use
OC Use
Sample
of cases
Population
with disease
(cases)
Sample
of controls
Much larger
population
without
disease
(controls)
No
Breast
Cancer
Breast
Cancer
OC Use
absent
OC Use
absent

78. Example of a Case-Control Study
CAD is less likely to those who consume garlic?

79. Case-Control Study
Patients with CAD
Patients w/o CAD
Present
Past
High Garlic Diet
High Garlic Diet
Low Garlic Diet
Low Garlic Diet
Cases
Controls

80. Case-Control Studies: Strengths
● Good for rare outcomes:
● Since the study begins with subjects who already have the outcome, it is
easier to accumulate enough subjects for significant results.
● Can examine many exposures
● Useful to generate hypothesis
● Fast
● Cheap
● Provides Odds Ratio

81. Case / Control Studies
Disadvantages
● Data Quality
● Data with inadequate detail, questionable reliability, or
use a different standard to judge disease severity.
● Recall bias
● Subjects who have unpleasant experiences may recall
past differently than control subjects.
● Cannot calculate prevalence or incidence and relative risk.
● Can only study one outcome
● Subject to confounding factors.

82. Correlational Research
Operational Definition:
A statistical analysis of covariant data to determine
a relationship. Researcher makes no attempt to
manipulate an independent variable.
Purpose:
This research technique is used to relate two or
more variables and allow predictions of
outcomes based on causative relationships
between the variables

83. Correlation and Significance
● Is there a relationship between two variables?
● What is the direction of the relationship?
● What is the magnitude?
● Pearson’s product moment coefficient correlation: -1.0
to +1.0

84. Correlation and Significance
A correlation refers to an association or a relationship between
two entities. A correlational research studies how one entity
impacts the other and what are the changes that are observed
when either one of them changes. This research method is
carried out to understand naturally occurring relationships
between variables.

85. The Process
● Participant and instrument selection
● Minimum of 30 subjects
● Instruments must be valid and reliable
● Higher validity and reliability requires smaller samples
● Lower validity and reliability requires larger samples
● Design and procedures
● Collect data on two or more variables for each subject
● Data analysis
● Compute the appropriate correlation coefficient

86. Research by Correlation
Figure 4.1 These three graphs represent hypothetical correlations between age and sleep problems.

88. Levels of correlation coefficient:
● 0.00 to 0.20 Negligible
● 0.20 to 0.40 Low
● 0.40 to 0.60 Moderate
● 0.60 to 0.80 Substantial
● 0.80 to 1.00 High to very high

89. Cohort Study
● Begin with disease-free patients
● Classify patients as exposed/unexposed
● Record outcomes in both groups
● Compare outcomes using relative risk

91. Cohort studies
● longitudinal
● Prospective studies
● Forward looking study
● Follow-up Study
● Incidence study

92. Activity III
Narrowing down your topic

93. Prospective Cohort

94. The Future
Outcome
Outcome
No Outcome
No Outcome
Prospective Cohort Design
The Present
Exposure present
Exposure absent
Sample
Population

96. The Future
Death
Death
No Death
No Death
Example of a Prospective Cohort Design:
Treatment of Severe Malaria in Children
The Present
Sample
PTX present
PTX absent
Population

98. General consideration while selection of cohorts
● Both the cohorts are free of the disease.
● Both the groups should equally susceptible to
disease
● Both the groups should be comparable
● Diagnostic and eligibility criteria for the disease
should be defined well in advance.

99. Example of a Cohort Study
To observe the effects of garlic use on CAD mortality in
a population?

100. Prospective Cohort Study
Garlic Free
Garlic
Eaters
No
CAD
CAD
CAD
No CAD
Present Future

101. Cohort studies
Strengths
● We can find out incidence rate
● More than one disease related to single exposure
● can establish cause - effect
● good when exposure is rare
● Eliminates recall bias
● minimizes selection and information bias
● Can calculate relative risk

102. Cohort Study: Weaknesses
● Expensive
● Time consuming
● Lost to follow-up
● Cannot study rare outcomes
● Confounding variables
● often requires large sample
● ineffective for rare diseases

103. What are RCTs?
● “A study where people are allocated randomly to
receiving a particular intervention or not (this
could be two different treatments or one
treatment and a placebo). This is the best type of
study design to determine whether a treatment
is effective.”
www.nhs.uk/news/Pages/Newsglossary.aspx

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RCT setup

106. Participants
Intervention Group (IG)
& Comparison Group (CG)
Outcome
I
G
CG
+ -
+
- D
C
B
A
Recruitment
VALIDITY
Maintenance
comparable groups?
treated equally?
compliant?
Measurements
blind
subjective? OR
objective?
QUESTION:
Allocation
concealment?

107. RAMMBO

108. www.cebm.net
Appraisal checklist - RAMMbo
Internal validity – minimising biases
Recruitment
• Who did the subjects represent?
Allocation
• Was the assignment to treatments randomised?
• Were the groups similar at the trial’s start?
Maintenance
• Were the groups treated equally?
• Were outcomes ascertained & analysed for most patients?
Measurements
• Were patients and clinicians “blinded” to treatment? OR
• Were measurements objective & standardised?
Study statistics (p-values & confidence intervals)
Guyatt. JAMA, 1993

109. www.cebm.net
Ensuring Allocation Concealment
BEST – most valid technique
Central computer randomization
DOUBTFUL
Envelopes, etc
NOT RANDOMIZED
Date of birth, alternate days, etc

110. www.cebm.net
Effects of non-equal treatment
Apart from actual intervention - groups should
receive identical care!
Trial of Vitamin E in pre-term infants (1948)
Vitamin E "prevented" retrolental fibroplasia
(By removal from 100% Oxygen to give the
frequent doses of Vitamin E!)
Rx: Give placebo in an identical regime, and a standard protocol

111. www.cebm.net
Intention-to-Treat Principle
Maintaining the randomization
Principle:
Once a patient is randomized, s/he should be
analyzed in the group randomized to - even if they
discontinue, never receive treatment, or crossover.
Exception: If patient is found on BLIND reassessment to
be ineligible based on pre-randomization criteria.

112. www.cebm.net
Measurement Bias
• Blinding – Who?
• Participants?
• Investigators?
• Outcome assessors?
• Analysts?
• Most important to use "blinded" outcome assessors
when outcome is not objective!
• Papers should report WHO was blinded and HOW it
was done
Schulz and Grimes. Lancet, 2002

113. www.cebm.net
Assessing the role of chance
• P-values (Hypothesis Testing)
• use statistical test to examine the ‘null’ hypothesis
• associated with “p values” - if p<0.05 then result is statistically
significant
• Confidence Intervals (Estimation)
• estimates a range of values that is likely to include the true
value

114. Clinical Question
In people who take long-haul flights
does wearing graduated compression
stockings prevent DVT?
Page 71 and 95 in your books

115. Participants
Intervention Group (IG)
& Comparison Group (CG)
Outcome
QUESTION:
VALIDITY

117. Summary
● Choose the best study design that matches the RQ
● Adhere to internal and external validity issues
● Cohort studies and RCT give the best evidence but are the
most time and money consuming
● Common mistakes: Conclude cause and effect
in a correlational study design.
● Tips:
Ø Weight strength of evidence with feasibility and time
Ø Teamwork
Ø Peer revision

118. References

119. msheikh@iau.edu.sa
Mona AlSheikh
@MonAlSheikh
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